Advances for adalimumab biosimilars in Saudi Arabia, Europe and Canada

Biosimilars/News | Posted 17/02/2023 post-comment0 Post your comment

In January 2023, Alvotech-Bioventure, Sandoz and Samsung Bioepis announced advances for their adalimumab biosimilars in Saudi Arabia, Europe and Canada, respectively. 

Adalimumab V13F21

Adalimumab is a monoclonal antibody used to treat a range of inflammatory conditions including rheumatoid arthritis, psoriatic arthritis, and inflammatory bowel disease (IBD) [1]. The reference product is AbbVie’s Humira.

The Alvotech adalimumab biosimilar, AVT02, has already received approval in many countries across the world as a high-concentration low-volume version of adalimumab, including Europe [2], Japan, Canada and Switzerland [3], under different partnerships and with brand names including Hukyndra, Libmyris and Simlandi. The Alvotech-Bioventure partnership now sees AVT02 approval by the Saudi Food and Drug Authority (SFDA) on 24 January 2023, where it will be marketed as Simlandi. 

Sandoz announced on 30 January 2023 that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), adopted a positive opinion for the marketing authorization of their citrate-free high concentration formulation (HCF) of its biosimilar Hyrimoz (adalimumab), the application was submitted on 17 June 2022 to EMA [4]. The authorization includes all indications covered by the reference medicine (Humira): rheumatoid arthritis, Crohn's disease, ulcerative colitis, plaque psoriasis, and uveitis.  Also, FDA has accepted Sandoz’s application for HCF of its adalimumab biosimilar Hyrimoz (GP2017) (adalimumab-adaz) on 21 July 2022 [5].

Samsung Bioepis announced on 3 January 2023 that Health Canada approved its HCF adalimumab biosimilar Hadlima (also known as SB5). Hadlima is indicated for the treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis, adult Crohn’s disease, ulcerative colitis, adult and adolescent hidradenitis suppurativa, plaque psoriasis, adult and paediatric uveitis. Now, both high- and low-dose formulations of the product are available in Canada [6].

Related articles
Humira (adalimumab) biosimilars pipeline

Switching from adalimumab originator and ABP501 to SB5 in arthritis patients

Canada approves five adalimumab biosimilars in last six months

LATIN AMERICAN FORUM
The new section of the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish.

View the latest headline article: DARS: avance el desarrollo de biosimilares en los EE. UU

Browse the news in the Latin American Forum!

Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative.

FORO LATINOAMERICANO
Se ha lanzado la nueva sección del ‘Foro Latinoamericano’ sobre GaBI. El objetivo de esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español.

Ver el último artículo de cabecera: DARS: avance el desarrollo de biosimilares en los EE. UU

!Explore las noticias en el Foro Latinoamericano!

Regístrese para recibir el boletín informativo GaBI Foro Latinoamericano. Informe a colegas y amigos sobre esta nueva iniciativa. 

 

References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of adalimumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Feb 17]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-adalimumab
2. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of two adalimumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Feb 17]. Available from:
www.gabionline.net/biosimilars/news/ema-recommends-approval-of-two-adalimumab-biosimilars
3. GaBI Online - Generics and Biosimilars Initiative. Advances for Alvotech’s partnerships in Japan, Canada and Switzerland [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Feb 17]. Available from:
www.gabionline.net/biosimilars/news/advances-for-alvotech-s-partnerships-in-japan-canada-and-switzerland
4. GaBI Online - Generics and Biosimilars Initiative. EMA accepts application for high concentration adalimumab biosimilar[www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Feb 17]. Available from:
www.gabionline.net/biosimilars/news/ema-accepts-application-for-high-concentration-adalimumab-biosimilar
5. GaBI Online - Generics and Biosimilars Initiative. FDA accepts application for high concentration adalimumab biosimilar[www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Feb 17]. Available from:
www.gabionline.net/biosimilars/news/fda-accepts-application-for-high-concentration-adalimumab-biosimilar
6. GaBI Online - Generics and Biosimilars Initiative. Samsung Bioepis launches Hadlima in Australia and Canada [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Feb 17]. Available from:
www.gabionline.net/biosimilars/news/Samsung-Bioepis-launches-Hadlima-in-Australia-and-Canada

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2023 Pro Pharma Communications International. All Rights Reserved.

comment icon Comments (0)
Post your comment
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010